INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
FDA premarket approval P980031/S013 · decided 2024-09-09
Approval details
- PMA number
- P980031
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 2023-10-02
- Decision date
- 2024-09-09
- Days to decision
- 343 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- approval for a manufacturing site located at AJL Ophthalmic, S.A., Ferdinand Zeppelin 1, Parque Tecnologico Alava, 01510 Minano, Araba, Spain, for manufacturing segment components, inspection, cleaning and primary packaging and sterilization of INTACS Corneal Implants
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